Kornimate/medical-research-clean huggingface dataset:
bioequivalency study of 7.5 mg pilocarpine under fed conditions

Conditions: Dry Mouth

Summary: the objective of this study was the bioequivalence of a roxane laboratories' pilocarpine tablets, 7.5 mg, to salagen® tablets, 7.5 mg (mgi) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to pilocarpine or any comparable or similar product.
strengthening program for foot-ankle muscles in people with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the main objective of this trial is to evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.

a randomized controlled trial will be performed with 76 patients with knee osteoarthritis. the participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty. the subjects will be evaluated in 3 different moments (baseline, immediately after treatment and 8 weeks follow-up). the hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.

Eligibility criteria:
inclusion criteria: * knee osteoarthritis (koa) based on clinical and radiological criteria of american college of reumathology; * koa (grade ii and iii - radiological classification of kellgreen and laurence) in medial compartment of knee; * knee pain between 30 and 80 on the visual analogue scale; * bmi \< 35 kg/m2. exclusion criteria: * koa isolated (grade ii and iii - radiological classification of kellgreen and laurence) in lateral compartment of knee; * lower limb strength training (3 times per week); * wear minimalist shoes for at least 6 hours a day and 5 days a week; * physical therapy in the previous 3 months; * having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively; * previous history of surgery on knees, ankles and hips in the last 2 years; * neurological disease; * inflammatory arthritis (eg. rheumatoid arthritis); * asymptomatic oa of one or both knees.

Keywords: rehabilitation arthrosis therapeutic exercises feet
qualitative survey about nurses first work experience during covid-19 pandemic

Conditions: Quality of Life

Summary: during covid-19 pandemic an huge reorganization of all piacenzahospital was done to manage the increasing requests for hosptitalization. new nurses had to face first work experience in full pandemic emergency. altough even before the pandemic, being a newly graduated nurses was described as a stressful and isolating experience , we can't find studies in the literatureconcerning newly graduated and newly hired nurses during the pandemic pediod. the study purpose is to describe and analyze, trough a phenomenological research, the experience of these nurses.


Eligibility criteria:
inclusion criteria: * adults * first work experience nurses after gratuation * not opposed to partecipate to this study exclusion criteria: * refusing to partecipate

Keywords: covid 19 first work experience nurse
indocyanine green test in bariatric surgery

Conditions: Obesity, Morbid; Surgery; Leak, Anastomotic

Summary: indocyanine green (icg) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time


Eligibility criteria:
inclusion criteria: * bmi\>40kg/m2 exclusion criteria: * non obese patients
prone duration in covid-19 ards

Conditions: COVID - 19; Acute Respiratory Distress Syndrome (ARDS)

Summary: the aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ards) due to coronavirus disease - 2019 (covid-19). the main question it aims to answer is: does the length of prone position duration affect gas exchange in patients with severe ards and is there a difference between genders in this regard? the differences in gas exchange between those who have been in prone position for 16-24 hours and those who have been in prone position for 24-36 hours as part of severe ards treatment will be examined.


Eligibility criteria:
inclusion criteria: * \>18 years old * hospitalized for more than 48 hours * patients diagnosed with covid-19 * intubated patients * underwent prone positioning for longer than 16 hours starting from the first session exclusion criteria: * pregnant females * patients under the age of 18 * those who did not reach 16 hours duration of prone position for various reasons (unintentional extubation, ventilation problems, hemodynamic instability, cardiac arrest-prearrest)

Keywords: covid - 19 acute respiratory distress syndrome prone position sex
investigating the biological effects of the addition of zoledronic acid to pre-operative chemotherapy in breast cancer

Conditions: Breast Cancer

Summary: there is clear preclinical in vitro and in vivo evidence of sequence dependent synergy between chemotherapy agents and zoledronic acid. the aim of the study is to investigate if the synergistic increase in tumour cell apoptosis observed in preclinical studies occurs in patients. the hypothesis for this study is that there may be anti-tumour benefits of the sequential application of chemotherapy agents followed by zoledronic acid in patients with invasive breast cancer.


Eligibility criteria:
inclusion criteria: * women with histological diagnosis of invasive breast cancer requiring neoadjuvant chemotherapy * t2 tumour or above * who performance status of 0,1 or 2 * must consent to or have undergone a core biopsy for diagnosis of breast cancer and consent to undergo an additional core biopsy prior to the second cycle of chemotherapy (day 5 +/- day 21) * written informed consent exclusion criteria: * previous chemotherapy or radiotherapy to treated breast * evidence of metastatic disease or recurrent breast cancer or previous malignancy (some exceptions) * calculated creatinine clearance \< 40mls/min * prior treatment with bisphosphonates in last year or known contraindications to bisphosphonate therapy * concurrent tamoxifen or aromatase inhibitor medication * pregnant or lactating women * cardiac dysfunction that precludes use of anthracycline chemotherapy * unwilling to have extra interim biopsy

Keywords: breast cancer zoledronic acid neoadjuvant chemotherapy synergy apoptosis
outcome after mtx & transvaginal surgery or uae & uterine curettage in patients with cesarean scar pregnancy

Conditions: Cesarean Scar Pregnancy; Menstruation

Summary: cesarean scar pregnancy (csp)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. no clinical guidelines have been issued for the management of csp. more than 30 treatment methods are reported to be used in managing csp. however, which management can achieve better clinical effects remains unknown. therefore, this prospective study is designed to compare the outcome between mtx + transvaginal surgery and uae + d\&c in the treatment of csp.


Eligibility criteria:
inclusion criteria: increased levels of serum β-hcg and ultrasonography findings. the criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. all patients had taken magnetic resonance imaging (mri) to clarify the diagnosis . pregnancy tissues were identified by histopathology examinations of the surgical tissues. exclusion criteria: all enrolled patients had no contraindications for transvaginal surgery or uae, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.

Keywords: cesarean scar pregnancy
norepinephrine and phenylephrine for spinal anesthesia-induced hypotension.

Conditions: Outcome

Summary: this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery ph undergoing cesarean section.

spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of spinal anesthesia-induced hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. the 2016 asa guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage spinal anesthesia-induced hypotension. the prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. however, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery ph and apgar score. the impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery ph undergoing cesarean section through a multicenter, single-blind, 2\*2 crossover and cluster randomized trial.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥37 weeks * american society of anesthesiologists physical status classification ii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension or baseline blood pressure ≥140 mmhg * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly

Keywords: spinal anesthesia-induced hypotension norepinephrine phenylephrine neonatal outcomes cesarean section
efficacy and safety of imatinib mesylate as first-line treatment for the patients with chronic phase of chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: this is a efficacy and safety study of imatinib mesylate capsule as first line treatment in patients with chronic phase of chronic myeloid leukemia.


Eligibility criteria:
inclusion criteria: * age≥18； * the new diagnosis of cml patients in six months； * no proof of extra-medullary infiltration of leukemia； * ecog ps score：0-2； * hepatic and renal functions are normal，serum bilirubin≤1.5\*uln, serum alt and ast≤2.5\*uln, serum cr≤1.5\*uln; * do not receive the treatment of anti-cml； * subjects signed informed consent form in line with gcp requirements。 exclusion criteria: * pregnant or lactating women； * received tkis any time before； * failure to control systemic infection or multiple organ failure； * according to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study； * being diagnosed with other malignancies in the prior 12 months； * have a history of neurological or psychiatric disorders, including epilepsy or dementia； * known or suspected allergy to imatinib； * bsa≤1.5m2； * using other experimental drugs or participating in other clinical trials in the prior one months。
check of optical features and accuracy of the zeiss zo lens after selection and calculation with okulix

Conditions: Cataract

Summary: it is planned to implant the intraocular lenses xl stabi zo and invent zo into the eyes of patients for whom a cataract operation is medically indicated. the lenses are marketed and ce certified. their implantation is clinical routine. in the trial the accuracy of prediction of target refraction and the difference between calculated and measured contrast vision will be examined for both lens types.


Eligibility criteria:
inclusion criteria: * indication for cataract operation * written informed consent of patient after information exclusion criteria: * immobility * limited capacity of understanding * diseases that hamper a follow-up examination * astigmatism \>2.0 d * patients with ocular diseases who may be expected to show a vision of less than 0.63 (decimal) two months after cataract surgery with implantation of intraocular lens * complications during surgery, especially complications with positioning of the intraocular lens and with capsulorhexis

Keywords: improvement of adjustment accuracy of intraocular lenses and imaging quality
treatment of local gingival recession with an enamel matrix protein coated collagen matrix

Conditions: Gingival Recession

Summary: the clinical trial studies patients with gingival recession defects (receding gums). the goal of the study is to test whether the additional use of enamel matrix derivatives (emd), combined with the use of a coronally advance flap (caf) and a cm (collagen matrix), shows a better outcome compared to a comparison group. the comparison group comprises patients receiving treatment with caf and cm without the use of emd.

the study aims to evaluate the influence of the additional use of emd in treatment of gingival recession defects using a coronally advance flap (caf) and a cm (collagen matrix) by means of digital and clinical assessment methods. the reference group comprises patients receiving treatment with caf and cm without the application of emd. in this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year. 15 patients with 24 gingival recession defects (recession type 1 after cairo/miller class i or ii) were recruited and were randomly assigned into the two treatment groups.

Eligibility criteria:
inclusion criteria: * signed informed consent * able to achieve good oral hygiene (full mouth plaque score \< 20 %, full mouth bleeding score \< 20%), * patients presenting with at least one gingival recession defect exclusion criteria: * general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus); * ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy; * self-reported heavy smokers (more than 10 cigarettes/day); * pregnancy and nursing mothers; * disorders or treatments that impair wound healing; * long-term treatment with high-dose steroids or anticoagulants; * bone metabolism disorders; * infections or vascular disorders in the region to be treated; * known hypersensitivity to porcine collagen; * patients with severe peripheral artery disease or autoimmune diseases; * extruded or malpositioned teeth.

Keywords: coronally advanced flap collagen enamel matrix protein dental enamel protein gingival recession periodontal plastic surgery
a phase iii study to evaluate efficacy of botulinum toxin for treating epicondylitis

Conditions: Epicondylitis

Summary: the study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months. as secondary objectives, the study aims to * demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities. * evaluate tolerance of treatment by grip strength measurement and adverse event collection.

this is a prospective multicenter phase iiib randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis. all patients will be randomized in 3 following parallel treatment groups: group a : botulinum toxin + corticoid group c : placebo of toxin + corticoid group t : botulinum toxin + placebo corticoid the study will be performed in 4 centers in france, targetting 150 patients. the follow-up of each patient will last 6 months after treatment.

Eligibility criteria:
inclusion criteria: * patient aged between 18 and 60 years; * physical disability or not; * unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, nsaids per os; * signed consent obtained; * covered by health insurance. exclusion criteria: * central nervous system disorders result in spasticity in epicondylitis limb; * history of severe psychiatric disorder; * history of myasthenia gravis; * pregnant or breastfeeding woman; * unable to understand or respond to questions; * contraindication to botulinum toxin or corticoid; * treatment with botulinum toxin 3 months prior to baseline; * anticoagulant theraphy; * difficult to follow-up in the study; * patient under guardianship, or deprived of liberty by a judicial order.

Keywords: epicondylitis botulinum toxin corticoid
social interventions for support during treatment for endometrial cancer and recurrence

Conditions: Endometrial Cancer

Summary: the sister study is a randomized trial, looking at various modalities of social support for black patients undergoing treatment for endometrial cancer. there are three study arms: group support, 1:1 peer support, and enhanced usual care. the primary outcome is treatment completion, and the secondary outcome is social isolation.

sister is a prospective, open randomized controlled trial of u.s. black/african-american people with high-risk endometrial cancer requiring treatment with chemotherapy, radiation, or immunotherapy. we will compare social support interventions of enhanced usual care, weekly group-based support, and 1:1 peer support to determine the most effective option to improve treatment completion and decrease social isolation. the sister study comparators are based on multiple systematic reviews of peer support literature, input from the multi-stakeholder steering group of the endometrial cancer action network for african americans (ecana), two focus groups of black women with ec, and cancer center leadership at selected enrollment sites. the core function of each comparator is to decrease social isolation for women on active treatment. of the peer support intervention options available, the sister study includes the two that have the most data collected among black women with cancer, have been most efficacious with regard to social isolation9 and treatment completion, and were enthusiastically supported by ecana patient partners and focus group data.

Eligibility criteria:
inclusion criteria: 1. adult 18 years of age or older; and 2. self-identify as black/african american 3. presenting with high-risk ec established by anatomic pathology as tumor stage and grade classification by the following: 1. pathology documentation from any hospital/clinic/medical center, and 2. figo stage 1a with grade 2, grade 3, or grade 4 of any histology type or 3. figo stage 1a with non-endometrioid (carcinosarcoma, serous, clear cell, undifferentiated or mixed) histology 4. figo stage 1b, 2, 3, or 4 of any grade or histology 5. recurrent endometrial cancer of any stage or grade 4. documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy. exclusion criteria: participants must not have any of the following exclusion criteria: 1. newly diagnosis of figo stage ia grade 1 endometrioid adenocarcinoma 2. previous history of other cancer diagnosis requiring chemotherapy, radiation therapy, or immunotherapy within the past 12 months; 3. incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening; 4. contraindication to all non-surgical therapy available for endometrial cancer (i.e., chemotherapy, radiation, and immunotherapy contraindicated); 5. enrollment into hospice prior to randomization 6. unable to provide written informed consent in english; 7. unable to be contacted for research surveys; 8. recent hospitalization for psychiatric illness in the past 6 months
attitudes about childbearing and fertility with inherited breast and ovarian cancer syndromes (hboc)

Conditions: Breast Cancer; Ovarian Cancer

Summary: objectives: - to evaluate the attitudes and opinions of women undergoing genetic counseling for hereditary breast and ovarian cancer syndrome, both before and after testing, in regards to pregnancy and fertility hypothesis: -factors that will increase the percentage of women endorsing prenatal diagnostic testing will include a personal history of breast or ovarian cancer, having had a mother or sister die of breast or ovarian cancer, and testing positive for a brca mutation.

this questionnaire is part of a study at the university of texas m.d. anderson cancer center. the purpose is to ask women who are seeking genetic testing for hboc their viewpoints surrounding fertility, childbearing and parenting, both at the time of testing and at the time of results disclosure. the aim is to evaluate if the genetics results disclosure may influence women's views regarding these topics. researchers hope to use this information to provide more information to the patient and the caregiver to help both parties with this very important cancer survivorship issue.

Eligibility criteria:
inclusion criteria: 1. women who have been referred to the clinical cancer genetics program for discussion of hereditary breast and ovarian syndrome (hboc). 2. participants must be seen by clinical cancer geneticist and undergo genetic counseling here at m.d. anderson cancer center for hboc. 3. participants may or may not have a personal diagnosis of cancer. 4. participants may have already seen or undergone reproductive endocrine evaluation and had any reproductive treatment. 5. the participant must be a woman and have reproductive potential which would include either active menstruation, blood tests with premenopausal ranges of luteinizing hormone (lh), follicle stimulating hormone (fsh) and estradiol, or was premenopausal prior to starting chemotherapy for a diagnosed breast cancer. 6. age \>/= 18 years old 7. the patient must be able to speak and read fluently in either english or in spanish in order to complete the questionnaire. exclusion criteria: 1) none

Keywords: ovary, cancer ovarian cancer breast cancer hereditary breast and ovarian cancer syndrome hboc genetic testing pregnancy fertility prenatal diagnostic testing